BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCU-CHEK SPIRIT

    MDR report key: 1052853 · Received May 27, 2008

    Report

    Report Number
    2183996-2008-00763
    Event Type
    Malfunction
    Date Received
    May 27, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    DISETRONIC MEDICAL SYSTEMS
    Product Code
    LZG
    PMA / PMN Number
    K060876
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Description of Event or Problem · 1

    IN 2008, THE PT REPORTED THAT HE WAS NOT ABLE TO COMPLETELY RETRACT HIS PISTON ROD DURING A CARTRIDGE CHANGE. THE INFUSION DEVICE DISPLAYED "RETURNING PISTON ROD" ON THE SCREEN BUT THE MOTOR WAS NOT RUNNING. THE BATTERY HAD BEEN IN USE FOR 3 DAYS. TO TROUBLESHOOT THE PT WAS INSTRUCTED TO INSERT A NEW BATTERY. HE WAS THEN ABLE TO COMPLETELY RETRACT THE PISTON ROD. THE PT REPORTED THAT HE DOES NOT DISCONNECT FROM THE INFUSION DEVICE WHILE SHOWERING. HE WAS ADVISED TO PROTECT THE INFUSION DEVICE FROM WATER CONTACT. HE STATED THAT OVER THE PAST FEW DAYS HE NOTICED MOISTURE IN THE CARTRIDGE COMPARTMENT AND DRIED THE MOISTURE WITH A COTTON SWAB. HE REPORTED "REDDISH TYPE STUFF" SIMILAR TO RUST AT THE BASE OF THE PISTON ROD. NO PHYSIOLOGICAL EFFECTS WERE REPORTED. THE PT DID NOT REQUIRE MEDICAL ASSISTANCE FROM A HEALTHCARE PROFESSIONAL OR SECOND PARTY TO ADDRESS THE ISSUE. PROD WAS REPLACED AND REQUESTED TO BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCU-CHEK SPIRIT INSULIN INFUSION PUMP LZG DISETRONIC MEDICAL SYSTEMS NA NA

    Patients

    Seq Age Sex Outcome Treatment
    1 INSULIN| INSULIN INFUSION SET